• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISIX - LASER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VISIX - LASER Back to Search Results
Event Date 05/30/2004
Event Type  Injury  
Event Description

Lasik eye surgery resulting in partial blindness in right eye.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISIX - LASER
Type of DeviceLASER
MDR Report Key1125943
Report NumberMW5008014
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 08/15/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/15/2008 Patient Sequence Number: 1
Treatment
20 DOCUMENTED OFFICE VISITS TO VARIOUS EYE
SURGEONS.
-
-